# K031371: Saphyre Bipolar Ablation Probes

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: May 23, 2003 after 23 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991218 (1999). 3 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000691: Vulcan Electrosurgical Probes: Vulcan Micro Ligament Chisels, Vulcan Ligament Chisels, Vulcan Eflex Ligament Chisels, Oratec Interventions, Inc. (2000) Summary page 1.
- K011083: Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand, Arthrocare Corp. (2001)
- K991218: Oratec Bipolar Ablation Probes, Oratec Interventions, Inc. (1999) Summary page 1.

## Most influential descendants
- K043442: Stryker RF Coaxial Bipolar Electrodes & Cannulae (2005), 17 descendants of its own
- K153272: INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set (2016), 7 descendants of its own
- K061660: Stryker RF Parallel Bipolar Adaptor Cable (2006), 5 descendants of its own
- K180369: Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) (2018), 4 descendants of its own
- K170827: INTRACEPT Intraosseous Nerve Ablation System (2017), 4 descendants of its own

## Indications for use
The Smith & Nephew Saphyre Bipolar Ablation Probes, in combination with the Smith & Nephew Vulcan EAS Generator, are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and in coagulating soft tissue in joints including but not limited to the knee, shoulder, wrist, hip, etc. Arthroscopic surgery could include a variety of procedures, as listed in the table below. All Joints: Debridement (tendon, cartilage, fracture), Plica Removal, Resection, Synovectomy, Bursectomy, Ablation, Excision of Soft Tissue (scar tissue), Hemostasis of Blood Vessels, Coagulating Soft Tissues (ligament, articular cartilage), and Chondroplasty. Knee: Meniscectomy, Meniscal Cystectomy, PCL/ACL Debridement, Notchplasty, Lateral Release, Labral Tear. Shoulder: Acromioplasty, Rotator Cuff Debridement, Subacromial Decompression CA Ligament Resection, and Capsular Release. Wrist: Triangular Fibrocartilage (TFC).

Source page: https://510kreport.com/device/K031371
Methodology: https://510kreport.com/methodology